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Neuroinflammation and Age-associated Brain Pathology: Two Potential Mechanisms of Cognitive Impairment in Breast Cancer

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
[11C]PiB and 18F-labeled DPA-714 PET scan
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. 50 years of age or older
  2. Female gender
  3. Newly diagnosed treatment naïve women with breast cancer that meet the following criteria:

Stage IIA: Any 1 of these conditions:

  1. There is no evidence of a tumor in the breast, but the cancer has spread to 1 to 3 axillary lymph nodes. It has no spread to distant parts of the body. (T0, N1, M0).
  2. The tumor is 20mm or smaller and has spread to the axillary lymph nodes (T1, N1, M0).
  3. The tumor is larger then 20mm but not larger than 50mm and has not spread to the axillary lymph nodes (T2, N1, M0).

Stage IIB: Either of these conditions:

  1. The tumor is larger than 20mm but not larger then 50mm and had spread to 1 to 3 axillary lymph nodes (T2, N1, M0).
  2. The tumor is larger than 50mm but has not spread to the axillary lymph nodes (T3, N0, M0).

StageIIIA:

1.The cancer of any size has spread to 4 to 9 axillary lymph nodes or to internal mammary lymph nodes. It has not spread to other parts of the body (T0, T1, T2, N2, M0). Stage IIIA may also be a tumor larger than 50mm that has spread to 1 to 3 axillary lymph nodes (T3, N1, M0).

4. High or mixed affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971.

5. English is primary language 6. Planned neoadjuvant chemotherapy with either a taxane or an anthracycline drug

Exclusion Criteria:

  1. Contraindication to PET/MRI, including claustrophobia
  2. Pregnancy
  3. Lactation
  4. Individuals who are unable to participate in the imaging portion due to severity of their medical condition
  5. Chronic infectious disease (e.g. HIV, HCV)
  6. Chronic inflammatory disease (e.g., fibromyalgia, MS, etc) or autoimmune disease
  7. Viral or bacterial illness requiring medical attention and/or antibiotics within 1 month of study participation
  8. Blood or blood clotting disorder
  9. Cancer that has metastasized to the brain
  10. Positive urine β-hCG test day of procedure or a serum hCG test within 48 hours prior to the administration of [18F]DPA-714 and [11C]PiB.
  11. Currently enrolled in a clinical trial utilizing experimental therapies.
  12. Low affinity binder for TSPO ligands based on genotyping for SNP rs6971.
  13. Prior brain tumor or other neurological condition known to affect cognition
  14. A diagnosis of dementia unrelated to cancer or an adjusted MMSE score < 24

Sites / Locations

  • The University of Alabama at BirminghamRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Women with stage 1-4 newly diagnosed breast cancer

Arm Description

Outcomes

Primary Outcome Measures

Measure neuroinflammation by calculating the concentration and regional distribution of activated brain microglia/macrophages using PET ligand [F-18]DPA-714.

Secondary Outcome Measures

Correlate cognitive testing and self-reporting before and after beginning cancer therapy with the concentration and regional brain distribution of pathologic amyloid deposition measured with the PET tracer [C-11]PiB prior to beginning therapy.
Cognitive testing: Hopkins Verbal Learning Test-Revised (HVLT-R), 10/36 Spatial Recall Test Trail Making Test Part A, PASAT Controlled Oral Word Association Test (COWAT) Trail Making Test Part B and the Night Out Task (NOT) Self-report measures: Compensation Strategy Questionnaire (Ecomp) Cognitive Failures Questionnaire HADS Distress Thermometer FACT

Full Information

First Posted
March 2, 2020
Last Updated
June 29, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT04364672
Brief Title
Neuroinflammation and Age-associated Brain Pathology: Two Potential Mechanisms of Cognitive Impairment in Breast Cancer
Official Title
Neuroinflammation and Age-associated Brain Pathology: Two Potential Mechanisms of Cognitive Impairment in Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2024 (Anticipated)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study will use a PET/MRI scanner and an investigational radioactive drug called [F-18]DPA-714 that measures inflammation in the brain, also called neuroinflammation, before chemotherapy and after 3 to 6 cycles of chemotherapy given as part of your clinical care. In addition, this study will use a PET/MRI scanner with an investigational radioactive drug called [C-11]PiB that measures the amount of abnormal protein (called beta-amyloid) in the brain that is a marker of Alzheimer's disease pathology. One of the most common complaints among breast cancer survivors is cognitive or memory problems especially in older adults. Researchers need to better understand the mechanisms and risk factors for cognitive problems in order to address this problem. This study seeks to examine two mechanisms, neuroinflammation and amyloid deposition, that have been suggested in other age-related cognitive disorders. This study may help physicians and researchers develop new treatments to protect the brain in cancer patients. UAB plans to enroll 20 participants in this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Women with stage 1-4 newly diagnosed breast cancer
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
[11C]PiB and 18F-labeled DPA-714 PET scan
Intervention Description
One PET with [11C]PiB and One PET with [18F]DPA-714 before chemotherapy treatment begins. One more PET with [18F]DPA-714 after completion of 3-6 cycles of chemotherapy.
Primary Outcome Measure Information:
Title
Measure neuroinflammation by calculating the concentration and regional distribution of activated brain microglia/macrophages using PET ligand [F-18]DPA-714.
Time Frame
Pre-study visit through 3-6 cycles of chemotherapy (each cycle is typically 2 weeks)
Secondary Outcome Measure Information:
Title
Correlate cognitive testing and self-reporting before and after beginning cancer therapy with the concentration and regional brain distribution of pathologic amyloid deposition measured with the PET tracer [C-11]PiB prior to beginning therapy.
Description
Cognitive testing: Hopkins Verbal Learning Test-Revised (HVLT-R), 10/36 Spatial Recall Test Trail Making Test Part A, PASAT Controlled Oral Word Association Test (COWAT) Trail Making Test Part B and the Night Out Task (NOT) Self-report measures: Compensation Strategy Questionnaire (Ecomp) Cognitive Failures Questionnaire HADS Distress Thermometer FACT
Time Frame
After pre-study visit and before starting chemotherapy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 50 years of age or older Female gender Newly diagnosed treatment naïve women with breast cancer that meet the following criteria: Stage IIA: Any 1 of these conditions: There is no evidence of a tumor in the breast, but the cancer has spread to 1 to 3 axillary lymph nodes. It has no spread to distant parts of the body. (T0, N1, M0). The tumor is 20mm or smaller and has spread to the axillary lymph nodes (T1, N1, M0). The tumor is larger then 20mm but not larger than 50mm and has not spread to the axillary lymph nodes (T2, N1, M0). Stage IIB: Either of these conditions: The tumor is larger than 20mm but not larger then 50mm and had spread to 1 to 3 axillary lymph nodes (T2, N1, M0). The tumor is larger than 50mm but has not spread to the axillary lymph nodes (T3, N0, M0). StageIIIA: 1.The cancer of any size has spread to 4 to 9 axillary lymph nodes or to internal mammary lymph nodes. It has not spread to other parts of the body (T0, T1, T2, N2, M0). Stage IIIA may also be a tumor larger than 50mm that has spread to 1 to 3 axillary lymph nodes (T3, N1, M0). 4. High or mixed affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971. 5. English is primary language 6. Planned neoadjuvant chemotherapy with either a taxane or an anthracycline drug Exclusion Criteria: Contraindication to PET/MRI, including claustrophobia Pregnancy Lactation Individuals who are unable to participate in the imaging portion due to severity of their medical condition Chronic infectious disease (e.g. HIV, HCV) Chronic inflammatory disease (e.g., fibromyalgia, MS, etc) or autoimmune disease Viral or bacterial illness requiring medical attention and/or antibiotics within 1 month of study participation Blood or blood clotting disorder Cancer that has metastasized to the brain Positive urine β-hCG test day of procedure or a serum hCG test within 48 hours prior to the administration of [18F]DPA-714 and [11C]PiB. Currently enrolled in a clinical trial utilizing experimental therapies. Low affinity binder for TSPO ligands based on genotyping for SNP rs6971. Prior brain tumor or other neurological condition known to affect cognition A diagnosis of dementia unrelated to cancer or an adjusted MMSE score < 24
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan McConathy, MD, PhD
Phone
205-996-7115
Email
jmcconathy@uabmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
April Riddle, BS RT
Phone
205-934-6504
Email
ariddle@uabmc.edu
Facility Information:
Facility Name
The University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan McConathy, MD, PhD
Phone
205-996-7115
Email
jmcconathy@uabmc.edu
First Name & Middle Initial & Last Name & Degree
April Riddle, BS RT
Phone
205-934-6504
Email
ariddle@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Pradeep Bhambhvani, MD
First Name & Middle Initial & Last Name & Degree
Gagandeep Choudhary, MD
First Name & Middle Initial & Last Name & Degree
Jeffers Charlotte Denise, RPh
First Name & Middle Initial & Last Name & Degree
Lapi Suzanne, PhD
First Name & Middle Initial & Last Name & Degree
Nabors Burt, MD
First Name & Middle Initial & Last Name & Degree
Stringer-Reasor Erica, MD
First Name & Middle Initial & Last Name & Degree
Rocque Gabrielle, MD
First Name & Middle Initial & Last Name & Degree
Triebel Gerstenecker Kristen, PsyD
First Name & Middle Initial & Last Name & Degree
Krontiras Helen, MD
First Name & Middle Initial & Last Name & Degree
Falkson Carla, MD
First Name & Middle Initial & Last Name & Degree
Nabell Lisle, MD
First Name & Middle Initial & Last Name & Degree
Keene Kimberly, MD
First Name & Middle Initial & Last Name & Degree
Lancaster Rachel, MD
First Name & Middle Initial & Last Name & Degree
Parker Catherine, MD
First Name & Middle Initial & Last Name & Degree
Jonathan McConathy, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Neuroinflammation and Age-associated Brain Pathology: Two Potential Mechanisms of Cognitive Impairment in Breast Cancer

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